BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CORUS Navigation Access System

    K Number: K240625 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    21
    Review Days
    58

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    Basic Information

    Device Name
    CORUS Navigation Access System
    K Number
    K240625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Providence Medical Technology, Inc.
    Date Received
    March 6, 2024
    Decision Date
    May 3, 2024
    Product Code
    OLO
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Providence Medical Technology, Inc.

    K Number Device Name
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    K251060 CORUS™ Navigation System-GX
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    K241035 PMT Posterior Cervical Stabilization System (PCSS)
    K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)
    K230297 PMT Expandable Cage (PMT EXP)
    K220951 PMT Facet Fixation System (PMT FFS)
    K212636 CORUS Spinal System-X
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